scholarly journals Ward-based Goal-Directed Fluid Therapy (GDFT) in Acute Pancreatitis (GAP) trial: study protocol for a feasibility randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (10) ◽  
pp. e028783 ◽  
Author(s):  
Farid Froghi ◽  
Fiammetta Soggiu ◽  
Federico Ricciardi ◽  
Kurinchi Gurusamy ◽  
Daniel S Martin ◽  
...  
Keyword(s):  
Acute Pancreatitis ◽  
Cardiac Output ◽  
Randomised Controlled Trial ◽  
Fluid Therapy ◽  
Controlled Trial ◽  
Feasibility Trial ◽  
Electrolyte Balance ◽  
Central Research ◽  
Goal Directed Fluid Therapy ◽  
Randomised Controlled

IntroductionAcute pancreatitis is an inflammatory disease of the pancreas with high risk of developing multiorgan failure and death. There are no effective pharmacological interventions used in current clinical practice. Maintaining fluid and electrolyte balance is the mainstay of supportive management. Goal-directed fluid therapy (GDFT) has been shown to decrease morbidity and mortality in surgical conditions with systemic inflammatory response. There is currently no randomised controlled trial (RCT) investigating the role of GDFT based on cardiac output parameters in patients with acute pancreatitis in the ward setting. A feasibility trial was designed to determine patient and clinician support for recruitment into an RCT of ward-based GDFT in acute pancreatitis, adherence to a GDFT protocol, safety, participant withdrawal, and to determine appropriate endpoints for a subsequent larger trial to evaluate efficacy.Methods and analysisThe GDFT in Acute Pancreatitis trial is a prospective two-centre feasibility RCT. Eligible adults admitted with new onset of acute pancreatitis will be enrolled and randomised into ward-based GDFT (n=25) or standard fluid therapy (n=25) within 6 hours from the diagnosis and continuing for the following 48 hours. Cardiac output parameters will be monitored with a non-invasive device (Cheetah NICOM; Cheetah Medical). The intervention group will consist of a protocolised GDFT approach consisting of stroke volume optimisation with crystalloid fluid boluses, while the control group will receive standard care fluid therapy as advised by the clinical team. The primary endpoint is feasibility. Secondary endpoints will include safety of the intervention, complications, mortality, admission to intensive care unit, cost and quality of life.Ethics and disseminationEthics approval was granted by the London Central Research Ethics Committee (17/LO/1235, project ID: 221872). The results of this trial will be presented to international conference with interest in general surgery and acute care and published in a peer-reviewed journal.Trial registration numberISRCTN36077283.

scholarly journals P-P06 Ward based goal directed fluid therapy (GDFT) in acute pancreatitis (GAP) trial: a feasibility randomised controlled trial [ISRCTN 36077283]

2021 ◽  
Vol 108 (Supplement_9) ◽  
Author(s):  
Farid Froghi ◽  
Fiammetta Soggiu ◽  
Federico Ricciardi ◽  
Cecilia Vindrola-Padros ◽  
Lefteris Floros ◽  
...  
Keyword(s):  
Acute Pancreatitis ◽  
Cardiac Output ◽  
General Surgery ◽  
Fluid Therapy ◽  
Early Stage ◽  
Controlled Trial ◽  
Severe Disease ◽  
Randomised Trial ◽  
Length Of Hospital Stay ◽  
Goal Directed Fluid Therapy

Abstract Background Goal directed fluid therapy (GDFT) based on cardiac output assessment has been shown to reduce complications and improve survival for people undergoing major general surgery. There are no reports of cardiac output evaluation being used to optimise the fluid administration for patients with acute pancreatitis who are in a general surgery admission ward. Methods The trial protocol has been published. 50 patients with acute pancreatitis were recruited, consented and randomly allocated to either ward-based GDFT with intravenous (IV) fluids administered based on stroke volume optimisation or standard ward care but with blinded cardiac output evaluation for 48 hours following hospital admission. Results Over a period of 20 months 50 of 142 screened patients were recruited demonstrating that it was feasible to recruit into a randomised trial of this nature in ward patients with acute pancreatitis. 36 (72%) completed the allocated 48 hours of goal directed fluids with 10 (20%) discharged within 48 hours and 4 withdrawals (3 GDFT and 1 SC).  Baseline characteristics of the groups were similar with only 3 participants having severe disease (6%, 1 GDFT, 2 SC). Similar volumes of IV fluids were administered in both groups (GDFT 5465 (1839) ml, SC 5211 (1745) ml). GDFT group had a lower heart rate, blood pressure and respiratory rate and improved oxygen saturations. GDFT was not associated with any harms. Complications of AP appear to be similar as was duration of stay in intensive care. Length of hospital stay was 5 (2.9) in GDFT and 6.3 (7.6) in SC groups. Conclusions Ward GDFT is feasible and shows a signal of possible efficacy in acute pancreatitis in this early-stage study. A larger multi-site RCT is required to confirm clinical and cost effectiveness.

scholarly journals Feasibility of 3-month melatonin supplementation for brain oxidative stress and sleep in mild cognitive impairment: protocol for a randomised, placebo-controlled study

BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e041500
Author(s):  
Zoe Menczel Schrire ◽  
Craig L Phillips ◽  
Shantel L Duffy ◽  
Nathaniel S Marshall ◽  
Loren Mowszowski ◽  
...  
Keyword(s):  
Oxidative Stress ◽  
Blood Pressure ◽  
Cognitive Impairment ◽  
Mild Cognitive Impairment ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Feasibility Trial ◽  
Controlled Study ◽  
Brain Oxidative Stress ◽  
Randomised Controlled

IntroductionMelatonin has multiple proposed therapeutic benefits including antioxidant properties, synchronisation of the circadian system and lowering of blood pressure. In this protocol, we outline a randomised controlled trial to assess the feasibility, acceptability and tolerability of higher dose (25 mg) melatonin to target brain oxidative stress and sleep disturbance in older adults with mild cognitive impairment (MCI).Methods and analysisThe study design is a randomised double-blind, placebo-controlled, parallel group trial. Forty individuals with MCI will be recruited from the Healthy Brain Ageing Clinic, University of Sydney and from the community, and randomised to receive either 25 mg oral melatonin or placebo nightly for 12 weeks. The primary outcomes are feasibility of recruitment, acceptability of intervention and adherence to trial medication at 12 weeks. Secondary outcomes will include the effect of melatonin on brain oxidative stress as measured by magnetic resonance spectroscopy, blood pressure, blood biomarkers, mood, cognition and sleep. Outcomes will be collected at 6 and 12 weeks. The results of this feasibility trial will inform a future conclusive randomised controlled trial to specifically test the efficacy of melatonin on modifiable risk factors of dementia, as well as cognition and brain function. This will be the first trial to investigate the effect of melatonin in the population with MCI in this way, with the future aim of using this approach to reduce progression to dementia.Ethics and disseminationThis protocol has been approved by the Sydney Local Health District Ethics Committee (X18-0077). This randomised controlled trial will be conducted in compliance with the protocol published in the registry, the International Conference for Harmonisation on Good Clinical Practice and all other applicable regulatory requirements. The findings of the trial will be disseminated via conferences, publications and media, as applicable. Participants will be informed of results of the study at the conclusion of the trial. Eligible authors will include investigators who are involved in the conception and design of the study, the conduct of the trial, the analysis of the results, and reporting and presentation of study findings.Trial registration numberAustralian and New Zealand Clinical Trials Registry (ANZCTRN 12619000876190).Protocol versionV.8 15 October 2020.

scholarly journals Hughes Abdominal Repair Trial (HART)—abdominal wall closure techniques to reduce the incidence of incisional hernias: feasibility trial for a multicentre, pragmatic, randomised controlled trial

BMJ Open ◽  
2017 ◽  
Vol 7 (12) ◽  
pp. e017235 ◽  
Author(s):  
Rhiannon L Harries ◽  
Julie Cornish ◽  
David Bosanquet ◽  
Buddug Rees ◽  
James Horwood ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Data Monitoring Committee ◽  
Feasibility Trial ◽  
Abdominal Wall Closure ◽  
Incisional Hernias ◽  
Mass Closure ◽  
Monitoring Committee ◽  
Randomised Controlled

ObjectivesIncisional hernias are common complications of midline abdominal closure. The ‘Hughes Repair’ combines a standard mass closure with a series of horizontal and two vertical mattress sutures within a single suture. There is evidence to suggest this technique is as effective as mesh repair for the operative management of incisional hernias; however, no trials have compared Hughes repair with standard mass closure for the prevention of incisional hernia formation. This paper aims to test the feasibility of running a randomised controlled trial of a comparison of abdominal wall closure methods following midline incisional surgery for colorectal cancer, in preparation to a definitive randomised controlled trial.Design and settingA feasibility trial (with 1:1 randomisation) conducted perioperatively during colorectal cancer surgery.ParticipantsPatients undergoing midline incisional surgery for resection of colorectal cancer.InterventionsComparison of two suture techniques (Hughes repair or standard mass closure) for the closure of the midline abdominal wound following surgery for colorectal cancer.Primary and secondary outcomesA 30-patient feasibility trial assessed recruitment, randomisation, deliverability and early safety of the surgical techniques used.ResultsA total of 30 patients were randomised from 43 patients recruited and consented, over a 5-month period. 14 and 16 patients were randomised to arms A and B, respectively. There was one superficial surgical site infection (SSI) and two organ space SSIs reported in arm A, and two superficial SSIs and one complete wound dehiscence in arm B. There were no suspected unexpected serious adverse reactions reported in either arm. Independent data monitoring committee found no early safety concerns.ConclusionsThe feasibility trial found no early safety concerns and demonstrated that the trial was acceptable to patients. Progression to the pilot and main phases of the trial has now commenced following approval by the independent data monitoring committee.Trial registration numberISRCTN 25616490.

scholarly journals Protocol for a feasibility trial for improving breast feeding initiation and continuation: assets-based infant feeding help before and after birth (ABA)

BMJ Open ◽  
2018 ◽  
Vol 8 (1) ◽  
pp. e019142 ◽  
Author(s):  
Kate Jolly ◽  
Jenny Ingram ◽  
Joanne Clarke ◽  
Debbie Johnson ◽  
Heather Trickey ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Infant Feeding ◽  
Feasibility Study ◽  
Breast Feeding ◽  
Controlled Trial ◽  
Feasibility Trial ◽  
Study Results ◽  
Service Staff ◽  
Before And After ◽  
Randomised Controlled

IntroductionBreast feeding improves the health of mothers and infants; the UK has low rates, with marked socioeconomic inequalities. While trials of peer support services have been effective in some settings, UK trials have not improved breast feeding rates. Qualitative research suggests that many women are alienated by the focus on breast feeding. We propose a change from breast feeding-focused interactions to respecting a woman’s feeding choices, inclusion of behaviour change theory and an increased intensity of contacts in the 2 weeks after birth when many women cease to breast feed. This will take place alongside an assets-based approach that focuses on the positive capability of individuals, their social networks and communities.We propose a feasibility study for a multicentre randomised controlled trial of the Assets feeding help Before and After birth (ABA) infant feeding service versus usual care.Methods and analysisA two-arm, non-blinded randomised feasibility study will be conducted in two UK localities. Women expecting their first baby will be eligible, regardless of feeding intention. The ABA infant feeding intervention will apply a proactive, assets-based, woman-centred, non-judgemental approach, delivered antenatally and postnatally tailored through face-to-face contacts, telephone and SMS texts. Outcomes will test the feasibility of delivering the intervention with recommended intensity and duration to disadvantaged women; acceptability to women, feeding helpers and professionals; and feasibility of a future randomised controlled trial (RCT), detailing recruitment rates, willingness to be randomised, follow-up rates at 3 days, 8 weeks and 6 months, and level of outcome completion. Outcomes of the proposed full trial will also be collected. Mixed methods will include qualitative interviews with women/partners, feeding helpers and health service staff; feeding helper logs; and review of audio-recorded helper–women interactions to assess intervention fidelity.Ethics and disseminationStudy results will inform the design of a larger multicentre RCT. The National Research Ethics Service Committee approved the study protocol.Trial registration numberISRCTN14760978; Pre-results.

scholarly journals Feasibility study of a randomised controlled trial to investigate the treatment of sarcoidosis-associated fatigue with methylphenidate (FaST-MP): a study protocol

BMJ Open ◽  
2017 ◽  
Vol 7 (12) ◽  
pp. e018532 ◽  
Author(s):  
Christopher Atkins ◽  
Richard Fordham ◽  
Allan B Clark ◽  
Andrea Stockl ◽  
Andrew P Jones ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Treatment Strategies ◽  
Poor Response ◽  
Primary Objective ◽  
University Hospital ◽  
Feasibility Trial ◽  
Central Research ◽  
Ethical Approval ◽  
Randomised Controlled ◽  
Treatment Of Sarcoidosis

IntroductionFatigue is a frequent and troublesome manifestation of chronic sarcoidosis. This symptom can be debilitating and difficult to treat, with poor response to the treatment. Symptomatic management with neurostimulants, such as methylphenidate, is a possible treatment option. The use of such treatment strategies is not without precedent and has been trialled in cancer-related fatigue. Their use in sarcoidosis requires further evaluation before it can be recommended for clinical practice.Methods and analysisThe Fatigue and Sarcoidosis—Treatment with Methylphenidate study is a randomised, controlled, parallel-arm and feasibility trial of methylphenidate for the treatment of sarcoidosis-associated fatigue. Patients are eligible if they have a diagnosis of sarcoidosis, significant fatigue (measured using the Fatigue Assessment Scale) and have stable disease. Up to 30 participants will be randomly assigned to either methylphenidate (20 mg two times per day) or identical placebo in a 3:2 ratio for 24 weeks. The primary objective is to collect data determining the feasibility of a future study powered to determine the clinical efficacy of methylphenidate for sarcoidosis-associated fatigue. The trial is presently open and will continue until July 2018.Ethics and disseminationEthical approval for the study was granted by the Cambridge Central Research Ethics Committee on 21 June 2016 (reference 16/EE/0087) and was approved and sponsored by the Norfolk and Norwich University Hospital (reference 190280). Clinical Trial Authorisation (EudraCT number 2016-000342-60) from the Medicines and Healthcare products Regulatory Agency (MHRA) was granted on 19 April 2016. Results will be presented at relevant conferences and submitted to appropriate journals following trial closure and analysis.Trial registration numberNCT02643732; Pre-results.

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